FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Olea Sphere V3.0
K Number: K152602
·
Decision Mar 3, 2016
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
6
Review Days
174
Basic Information
- Device Name
- Olea Sphere V3.0
- K Number
- K152602
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OLEA MEDICAL
- Date Received
- September 11, 2015
- Decision Date
- March 3, 2016
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by OLEA MEDICAL
| K Number | Device Name | ||
|---|---|---|---|
| K132095 | OLEA SPHERE | Dec 26, 2013 | Substantially Equivalent |
| K120196 | OLEA SPHERE | Apr 19, 2012 | Substantially Equivalent |
| K111161 | PERFSCAPE V2.0 | Nov 4, 2011 | Substantially Equivalent |
| K091444 | PERFSCAPE | Jul 20, 2009 | Substantially Equivalent |
| K083491 | NEUROSCAPE | Feb 19, 2009 | Substantially Equivalent |